N/A
N=50
Randomized Comparison of Low and Conventional Irradiance PDT for Skin Cancer
Non-melanoma Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02872909 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Pain on VAS Score — 2.95; 1.25 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ambulight (Ambicare Health) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Sally Ibbotson
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain on VAS Score |
2.95; 1.25 | <0.05 sig |
| SECONDARY Phototoxicity |
2; 1 | — |
| SECONDARY Clinical Clearance of Lesion |
27; 14 | — |
| SECONDARY Patient Satisfaction |
10; 10 | <0.05 sig |
Summary
This study aims to examine whether the pain of topical photodynamic therapy (PDT) is significantly different when using low irradiance ambulatory light emitting diode (LED) devices compared with conventional higher irradiance hospital based LED light sources when used for superficial non-melanoma skin cancer. The investigators are also investigating the phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical trial.
Eligibility Criteria
Inclusion Criteria
- Bowen's disease or superficial basal cell carcinoma referred for PDT and lesion not greater than 2.4cm diameter
Exclusion Criteria
- Unable to give consent, >2cm diameter, lesions on highly curved surfaces where ambulatory device would not adhere
Data sourced from ClinicalTrials.gov (NCT02872909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.